Normal Polysomnography Values in Healthy Children and Adolescents in China (PSGNV)

May 2, 2016 updated by: Xin Ni, Beijing Children's Hospital

Research to Characterize Normal Polysomnography Values in Healthy Children and Adolescents in China

The study is designed to investigate normal polysomnographic respiratory values of Chinese healthy children and adolescents. By collecting the polysomnography (PSG) data and parameters of respiratory and sleep architecture，we hope to characterize normal polysomnography values in Chinese children and adolescents and to establish respiratory reference values for pediatric polysomnography which based on Chinese children's data.

Study Overview

Status

Unknown

Conditions

Detailed Description

We plan to recruit 200 healthy, normal children and adolescents in this study, age ranging from 3 to 15 years. All of them will be invited to undergo an overnight polysomnography for at least 7h in Beijing Children's Sleep Center, meanwhile the parameters about sleep including EEG, electromyography, electrooculography, ECG, pulse oximetry arterial oxygen saturation (SpO2), chest wall and abdomen motion, oral and nasal airflow, and end-tidal PCO2 (PETCO2) will be recorded.

Based on the data we hope to give recommendation of normal PSG parameters of Chinese kids, and on this basis,to develop the diagnosis creteria for obstructive sleep apnea syndrome which will be more suitable for Chinese children conditions.

Study Type

Observational

Enrollment (Anticipated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100045
        • Recruiting
        • Children's Sleep Center，Beijing,China
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

3 to 14-year-old healthy children from the community of China

Description

Inclusion Criteria:

1.3 to 14-year-old children 2.from the community of China 3.healty children

Exclusion Criteria:

  1. children with nocturnal snoring, continuous mouth breathing, difficulty breathing and apnea when sleep.
  2. children with craniofacial abnormalities, such as Down's syndrome, Crouzon syndrome, achondroplasia, mandibular hypoplasia and facial mandibularetc hypoplasia.
  3. children with history of upper respiratory tract infection nearly two weeks.
  4. children with adenoids, tonsils, throat, glottis, trachea, lungs and history of thoracic surgery.
  5. children with nose-sinusitis, allergic rhinitis, asthma, acut or purulent tonsillitis acute phase.
  6. children with any medical or surgicaldiseases.
  7. children who have to use use sedation to maintain sleep.
  8. parents or child not understand the study or do not agree to take part in.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Preschool group
3-6 years old
school age group
7-12 years old
Adolescence group
13-15 years old

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
obstructive apneas per hour of sleep
Time Frame: 7 hours of sleep
7 hours of sleep

Secondary Outcome Measures

Outcome Measure
Time Frame
minimum oxygen desaturation of sleep
Time Frame: 7 hours of sleep
7 hours of sleep
central apneas per hour of sleep
Time Frame: 7 hours of sleep
7 hours of sleep

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Children's Hospital

Investigators

  • Study Director: Xin Ni, MD PHD, Beijing Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

May 2, 2016

First Submitted That Met QC Criteria

May 2, 2016

First Posted (Estimate)

May 4, 2016

Study Record Updates

Last Update Posted (Estimate)

May 4, 2016

Last Update Submitted That Met QC Criteria

May 2, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCH-OSAHS-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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